Circular No. 35/2012/TT-BLDTBXH stipulates the procedures for designating organizations to certify conformity, announce conformity of products and goods under the management responsibility of the Ministry of Labor, Invalids and Social Affairs.

CIRCULAR

Circular stipulates the procedures for designating certification organizations and announcing conformity declarations for products and goods under the management responsibility of the Ministry of Labor, Invalids and Social Affairs.

announcing conformity declarations for products and goods on November 21, 2007; of

Based on Decree No. 186/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Labor, Invalids and Social Affairs;

___________

 

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to the Law on Product and Goods Quality dated November 21, 2007; Actual status of operation of equipment Decree No. 36/2012/NĐ-CP dated April 18, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of Ministries and ministerial-level agencies;

The Minister of Labor, Invalids and Social Affairs issues this Circular stipulating the procedures for designating certification organizations and announcing conformity declarations for products and goods under the management responsibility of the Ministry of Labor, Invalids and Social Affairs.

The Minister of Science and Technology hereby promulgates the regulations on the application of technical standards and regulations for nuclear safety in site selection, design, construction, operation, and decommissioning of nuclear power plants.

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Product Quality Law;

Article 1. This Circular specifies the procedures for designating certification organizations and announcing conformity declarations for:

At the proposal of the Director of the Occupational Safety and Health Inspectorate;

a) Products and goods that have the potential to cause safety hazards under the management responsibility of the Ministry of Labor, Invalids and Social Affairs;

Article 1. Scope of Regulation

b) Services, processes, and environments under the responsibility of the Ministry of Labor, Invalids and Social Affairs for issuing national technical regulations on occupational safety and health.

Products and goods, services, processes, and environments under the management responsibility of the Ministry of Labor, Invalids and Social Affairs as specified in Clause 1 of this Article shall hereinafter be referred to as products and goods.

This Circular applies to agencies, organizations, and individuals related to activities of certification and announcement of conformity declarations for products and goods within the scope of management of the Ministry of Labor, Invalids and Social Affairs.

Article 3. Activities of certification and announcement of conformity declarations

Article 2. Applicability

1. The Ministry of Labor, Invalids and Social Affairs designates the General Directorate of Occupational Safety and Health as the Lead Agency responsible for managing activities of certification and announcement of conformity declarations for products and goods (hereinafter referred to as the Lead Agency).

2. Certification and announcement of conformity declarations are mandatory activities for organizations and individuals producing and trading in products and goods according to the corresponding national technical regulations issued by the Ministry of Labor, Invalids and Social Affairs.

3. Certification of conformity for products and goods is carried out by certification organizations designated by the Lead Agency.

Article 4. Methods of conformity assessment

1. The methods of conformity assessment applicable to specific types of products and goods are stipulated in the corresponding national technical regulations issued by the Ministry of Labor, Invalids and Social Affairs.

2. In cases where the method of assessment has not been specifically stipulated in the corresponding national technical regulations, the certification organization must clearly state the method of assessment in the assessment procedure and process to assess products and goods according to the requirements of the corresponding national technical regulations; such assessment can only be conducted with the approval of the Lead Agency.

Article 5. Conformity Mark

1. The Conformity Mark (CR) has the shape and size as prescribed in Appendix 1 attached to this Circular.

2. The Conformity Mark must be displayed on packaging, labels, or directly on the products and goods mentioned in Point a, Clause 1, Article 1 of this Circular, in a visible and readable position, and must also be printed in accompanying technical documentation (if any).

3. The Conformity Mark may be enlarged or reduced but must maintain the correct ratio and be recognizable to the naked eye.

4. The Conformity Mark must be presented in the same color and be easily recognizable.

3. The conformity mark may be enlarged or reduced but must ensure the correct ratio and be recognizable to the naked eye.

4. The conformity mark must be displayed in the same color and be easily distinguishable.

Article 6. Conditions for organizations designated

1.1.1. Have registered their scope of certification activities at the Ministry of Science and Technology according to Circular No. 08/2009/TT-BKHCN dated April 8, 2009, issued by the Minister of Science and Technology, guiding on requirements, procedures, and procedures for registering the scope of compliance assessment activities;

Clause 1. Legally established, having functions to operate in the field of certification.

2. The management system and operational capacity of certification organizations must meet the requirements specified in national standards, international standards, and relevant international guidelines for each corresponding type as follows:

a) National standard TCVN 7457:2004 or international standard ISO/IEC Guide 65:1996 and related guidelines of the International Accreditation Forum (IAF) for product certification activities involving potentially hazardous goods as stipulated in point a, Clause 1, Article 1 of this Circular;

b) National standard TCVN ISO/IEC 17021:2008 or international standard ISO/IEC 17021:2006 and related guidelines of the International Accreditation Forum (IAF) for conformity assessment services, processes, and environmental activities as stipulated in point b, Clause 1, Article 1 of this Circular.

3. There must be at least five full-time staff evaluators belonging to the organization's permanent establishment (including civil servants or employees under contracts of at least 12 months or indefinite-term contracts) and meeting the following requirements:

a) Hold a bachelor’s degree or higher in a relevant field corresponding to the products or goods to be certified;

b) Have at least five consecutive years of direct experience related to the products or goods being evaluated;

c) Possess evaluation capabilities that comply with the provisions of national standard TCVN ISO 19011:2003 or international standard ISO 19011:2002 - Guidelines for quality management systems and/or environmental management systems auditing;

d) Have been trained in management system certification.

4. Must have adequate physical and technical facilities including offices, technical documents, necessary standards, and appropriate certification procedures.

Article 7. Procedures and formalities for designating conformity assessment organizations

1. Certification organizations wishing to participate in conformity assessment activities for products and goods must prepare one set of registration documents and submit them directly or via postal service to the Lead Agency.

2. Contents of the registration documents

a) A registration form for conformity assessment activities according to the model prescribed in Appendix 2 of this Circular;

b) A certified copy of the decision on establishment or business registration certificate or investment permit;

c) A certified copy of the registration certificate for the certification activity field issued by the Ministry of Science and Technology;

d) A list of evaluators meeting the requirements stipulated in Clause 3, Article 6 of this Circular, according to the model prescribed in Appendix 3 of this Circular accompanied by a certified copy of the corresponding training certificate;

đ) A list of technical documents including: necessary technical standards, relevant technical regulations, and certification procedures consistent with the corresponding national technical regulations according to the model prescribed in Appendix 4 of this Circular;

e) Content of conformity assessment procedures for products and goods;

g) Documents proving the capability of certification activities:

- For organizations that have been assessed and granted accreditation certificates for certification activities in Vietnam by legitimate accreditation organizations in Vietnam or members of the International Accreditation Forum (IAF) and the Pacific Accreditation Cooperation (PAC - The Pacific Accreditation Cooperation): Submit a certified copy of the accreditation certificate along with the scope of accreditation;

- For organizations that have not yet been accredited: Submit documents to prove the capability of certification activities in compliance with the requirements stipulated in Clause 2, Article 6 of this Circular;

h) Sample Certificate of Conformity;

i) Results of conformity assessment activities already conducted in the registered field (if any).

3. Within no more than 20 working days from the date of receiving complete and valid documents, the Lead Agency will review the documents, conduct an actual capability assessment at the premises (if necessary), and issue a decision to designate conformity assessment organizations according to the model prescribed in Appendix 5 of this Circular. In case of refusal to designate, the Lead Agency must notify the reasons for refusal in writing to the registering organization.

4. The validity period of the designation decision shall not exceed three years. Three months before the expiration of the conformity assessment organization designation decision, if there is a need, the conformity assessment organization must re-register according to the provisions of Clause 1 and Clause 2 of this Article.

5. When there is a need to change or supplement the scope of conformity assessment products and goods, the conformity assessment organization designated by the Lead Agency must re-register according to the provisions of Clause 1 and Clause 2 of this Article.

Article 8. Suspension or Revocation of the Designation Decision

1. The designation decision for the Certification Organization shall be suspended in the following cases:

a) The results of surveillance assessment or spot-check assessment by the Competent Authority show that the Certification Organization does not meet the conditions for designation or has not remedied the non-conformities identified in the previous assessment round;

b) The Certification Organization fails to comply with the requirements for inspection and surveillance assessment as requested by the competent state authority;

c) The Certification Organization does not fully implement the reporting system as stipulated at point o, Clause 2, Article 9 of this Circular.

2. The designation decision for the Certification Organization shall be revoked in the following cases:

a) The Certification Organization violates the scope of products or goods designated;

b) The Certification Organization has been suspended from the designation decision but is still found to be conducting certification activities;

c) The Certification Organization falsifies or alters the content of the designation decision;

d) The Certification Organization dissolves or ceases operations in the designated field;

e) The Certification Organization does not remedy the non-conformities recorded in the evaluation report or supervision inspection report, and does not implement the reporting system when the designation decision is suspended for a period of six months.

3. For other violations not mentioned in Clauses 1 and 2 of this Article, the Minister of Labor, Invalids and Social Affairs shall consider and decide.

4. In case the designation decision for the Certification Organization is revoked, the certification results of the Certification Organization from the time of the last supervision inspection until the revocation of the designation decision will no longer be valid.

Article 9. Rights and Obligations of the Certification Organization

1. Rights of the Certification Organization:

a) To conduct conformity certification of products or goods based on contracts signed with organizations or individuals requesting conformity certification within the scope of products or goods designated by the Competent Authority;

b) To be paid annual assessment and surveillance costs according to agreements with organizations or individuals producing or trading products or goods requiring conformity certification, or as prescribed by the competent state authority;

c) To provide conformity assessment results to organizations or individuals whose products or goods have been assessed for conformity; to issue a conformity certificate valid for no more than three years for products or goods certified as conforming to relevant technical regulations;

d) To grant and guide the use of the conformity mark to organizations or individuals whose products or goods have been certified for conformity;

đ) To issue new, reissue, or expand the scope of conformity certification for organizations or individuals whose products or goods have been certified for conformity;

e) To narrow the scope of conformity certification or temporarily suspend, revoke the conformity certificate and the right to use the conformity mark issued when the organization or individual whose products or goods have been certified for conformity violate the provisions on conformity certification;

g) To refuse to provide information related to testing, appraisal, inspection, and conformity certification results of products or goods to third parties, except when required by the competent state authority;

h) To be recognized by the competent state authority regarding the conformity assessment results according to the law.

2. Obligations of the Certification Organization:

a) To meet the requirements stipulated in Article 6 of this Circular;

b) To carry out conformity certification activities within the scope of products or goods designated according to the prescribed procedures and formalities. It may not refuse to provide services without a legitimate reason;

c) To pay the designated assessment fee to the Competent Authority as prescribed by current laws;

d) Based on the conformity assessment methods specified in the relevant technical regulations, to establish procedures and formalities for conformity certification for specific products or goods and notify relevant authorities, organizations, and individuals;

đ) To keep confidential information, data, and conformity assessment results of the assessed organization, except when required by the competent state authority;

e) To ensure transparency, independence, objectivity, accuracy, and non-discrimination in the origin of goods and organizations or individuals in conformity certification activities;

g) To monitor products or goods that have been certified for conformity to ensure their continued compliance with relevant technical regulations;

h) To promptly report to the competent management authority and widely announce through mass media about issuing new, reissuing, expanding, narrowing the scope of conformity certification or temporarily suspending, revoking the conformity certificate and the right to use the conformity mark;

i) To accept inspections and audits by the competent state authority regarding conformity certification activities;

k) To be responsible under the law for the results and activities of conformity certification;

l) To pay fines to organizations or individuals whose products or goods have been assessed if incorrect conformity certification results are provided. The fine amount is agreed upon by both parties in the contract, but it cannot exceed ten times the assessment cost. If the parties cannot agree, the fine amount will be decided by arbitration or court, but it cannot exceed ten times the assessment cost;

m) To compensate for losses incurred by organizations or individuals requesting conformity certification due to providing incorrect results, according to civil law regulations. Organizations or individuals whose products or goods have been certified for conformity must prove the incorrect result and the fault of the conformity certification organization;

n) To notify the Competent Authority of changes affecting its conformity certification capacity within fifteen days from the date of change;

o) To report annually (before January 10 of the following year) and on demand, the results of conformity certification activities according to the model prescribed in Appendix 6 of this Circular to the Competent Authority.

Article 10. Procedures for Announcement of Compliance

The announcement of compliance shall be carried out as follows:

1. Step 1: Evaluate the conformity of products and goods with corresponding technical regulations.

a) The conformity assessment must be conducted by a designated conformity certification organization.

b) The results of the conformity assessment for products and goods serve as the basis for organizations and individuals producing and trading to announce compliance.

2. Step 2: Register the announcement of compliance with the Department of Labor, Invalids, and Social Affairs where the organization or individual registers their production and trading activities.

Article 11. Registration of Announcement of Compliance

1. Organizations and individuals announcing compliance must prepare one set of registration documents and submit them directly or via postal service to the Department of Labor, Invalids, and Social Affairs where they register their production and trading activities for registration.

The registration documents for the announcement of compliance include:

a) A declaration of compliance according to the model prescribed in Appendix 7 of this Circular;

b) A certified copy of the certificate of conformity issued by a designated conformity certification organization;

c) A general description of the product or good (characteristics, features, functions, usage instructions);

d) A certified copy of the test results of the product or good.

2. Within five working days from the date of receipt of the compliance announcement registration documents:

a) If the documents comply with the provisions of Clause 1 of this Article, the Department of Labor, Invalids, and Social Affairs will notify in writing the organization or individual announcing compliance about the acceptance of the declaration of compliance according to the model prescribed in Appendix 8 of this Circular;

b) In case the documents do not meet the requirements stipulated in Clause 1 of this Article, the Department of Labor, Invalids, and Social Affairs will notify in writing the organization or individual announcing compliance about the points and contents that are not in compliance so that they can complete and re-register.

Article 12. Responsibilities of Organizations and Individuals Announcing Compliance

1. Bear responsibility for the conformity of products and goods that have been announced as compliant; maintain quality control and periodic monitoring of enterprises.

2. Use the compliance mark on products and goods that have been announced as compliant before putting them into circulation on the market. Maintain a record and periodically report the use of the compliance mark to the conformity certification organization.

3. When discovering non-conformity of products and goods that have been announced as compliant with technical standards during production, circulation, operation, and use, they must:

a) Timely notify relevant management agencies about the non-conformity;

b) Implement measures to address the non-conformity. If necessary, temporarily halt production and recall non-compliant products and goods currently circulating on the market;

c) Report in writing to management agencies about the results of addressing the non-conformity before continuing to put the products and goods into use, circulation, exploitation, and trading.

4. Retain the announcement of compliance documents as a basis for inspection and supervision by state management agencies.

5. Reannounce when there is any change in the content of the previously registered announcement of compliance.

Article 13. Responsibilities of Management Agencies

1. The lead agency has the responsibility to:

a) Receive, process registration documents, and issue decisions designating conformity certification organizations for products and goods under the management of the Ministry of Labor, Invalids, and Social Affairs;

b) Establish and publicly announce on the website of the Occupational Safety and Health Inspection Bureau the list of designated conformity certification organizations, and simultaneously inform the Ministry of Science and Technology for coordinated management;

c) Manage and inspect the conformity assessment activities of designated conformity certification organizations. Apply warning measures, suspend the effectiveness, or revoke the designation decision when the conformity assessment organization violates the provisions of this Circular. Announce on the website of the Occupational Safety and Health Inspection Bureau the name of the designated conformity assessment organization that has been suspended or had its designation revoked, and simultaneously inform the Ministry of Science and Technology for coordinated management;

d) Assist the Ministry of Labor, Invalids, and Social Affairs in unified management and guiding conformity certification and compliance announcement activities as prescribed in this Circular;

e) Annually report to the Ministry of Labor, Invalids, and Social Affairs on the situation of conformity certification and compliance announcement activities.

2. Provincial Departments of Labor, Invalids, and Social Affairs have the responsibility to:

a) Coordinate with the lead agency in supervising, inspecting, urging, and guiding the implementation of conformity certification and compliance announcement activities as prescribed in this Circular;

b) Receive registration documents for compliance announcements; issue confirmation notifications of compliance announcements, maintain records, and manage compliance announcement documents according to the model in Appendix 9 of this Circular;

c) Summarize and report to the Ministry of Labor, Invalids, and Social Affairs on the situation of compliance announcement activities upon request.

Article 14. Effective Date

1. This Circular takes effect from February 11, 2013.

2. During the implementation of this Circular, if there are any difficulties, we request individuals and organizations to reflect them to the Occupational Safety and Health Inspection Bureau of the Ministry of Labor, Invalids, and Social Affairs for research and resolution./.

ANNEX 1

SAMPLE OF THE COMPLIANCE MARK
(Annexed to Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012, of the Minister of Labor, Invalids, and Social Affairs)

 

 

ANNEX 2

SAMPLE OF REGISTRATION FOR CONFORMITY CERTIFICATION ACTIVITY
(Annexed to Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012, of the Minister of Labor, Invalids, and Social Affairs)

 

SOCIALIST REPUBLIC OF VIET NAM

Independence - Freedom - Happiness
 

..., day ..., month ..., year 20...

 

REGISTRATION DECISION

 CONFORMITY CERTIFICATION ACTIVITY

Respectfully submitted to: Occupational Safety and Health Inspection Bureau, Ministry of Labor, Invalids, and Social Affairs

 

1. Name of Organization:...

2. Contact Address: …

Telephone:...Fax: ...Email: ...

3. Establishment Decision/ (if applicable), Business Registration Certificate number... Issuing Authority: ...issued on ...at ...

4. Attached Documents:

- .....

- .....

5. After studying the conditions for conducting conformity certification activities as prescribed in Decree No. 132/2008/ND-CP dated December 31, 2008, of the Government detailing the implementation of certain articles of the Law on Product Quality and Goods, and Decree No. 127/2007/ND-CP dated August 1, 2007, of the Government detailing the implementation of certain articles of the Law on Standards and Technical Regulations; Circular No. .../2012/TT-BLDTBXH dated ...month ...year 2012 of the Minister of Labor, Invalids, and Social Affairs guiding conformity certification and compliance announcement activities, we find that we meet all the conditions to conduct conformity certification activities for the following products and goods:

- .............. (products, goodsa)

We respectfully request the Occupational Safety and Health Inspection Bureau to consider and designate (name of organization) to conduct conformity certification activities for the corresponding products and goods.

We hereby commit to comply with all regulations regarding conformity assessment activities./.

 

 

 

 

ANNEX 3

SAMPLE LIST OF EXPERTS FOR ASSESSMENT BY THE CERTIFICATION ORGANIZATION
(Annexed to Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012, of the Minister of Labor, Invalids, and Social Affairs)

 

NAME OF THE ORGANIZATION: …

LIST OF EXPERTS FOR ASSESSMENT

OF CERTIFICATION ORGANIZATION REGISTERED AND DESIGNATED

 

 

 

 

ANNEX 4

SAMPLE DOCUMENT DIRECTORY FOR CERTIFICATION ACTIVITIES
(Annexed to Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012, of the Minister of Labor, Invalids, and Social Affairs)

 

NAME OF THE ORGANIZATION:…

DOCUMENT DIRECTORY FOR CERTIFICATION ACTIVITIES

 

 

 

 

ANNEX 5

SAMPLE DECISION ON DESIGNATION OF CONFORMITY CERTIFICATION ORGANIZATION
(Annexed to Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012, of the Minister of Labor, Invalids, and Social Affairs)

Pursuant to …;

Regarding the designation of certification organization

DIRECTOR OF THE DIRECTORATE OF OCCUPATIONAL SAFETY AND HEALTH

Pursuant to Decision No... dated …/.../…of …regarding the functions, tasks, powers, and organizational structure of the Directorate of Occupational Safety and Health;

Pursuant to Circular No…./2012/TT-BLDTBXH dated…month ...year 2012 of the Minister of Labor, Invalids and Social Affairs on the designation of conformity certification, declaration of conformity for products and goods under the responsibility of the Ministry of Labor, Invalids and Social Affairs;

Upon the proposal of …(name of unit under the Directorate of Occupational Safety and Health assigned to review registration files),

DECISION:

Article 1) Designate …(name of certification organization) belonging to...(name of the parent organization, if any), address…to carry out conformity certification …(name of product field, goods designated) in accordance with national technical regulations…(name of the technical standard, number).

Article 2. The validity period of this Decision is three years from the date of issuance.

Article 3The organization…(name of certification organization) shall be responsible for carrying out conformity certification to serve state management when requested and must comply with relevant regulations and guidelines of competent authorities.

Article 4The organization named in Article 1 and related agencies and organizations shall be responsible for implementing this Decision./.

ANNEX 6

SAMPLE REPORT ON CERTIFICATION ACTIVITY STATUS
(Annexed to Circular No. 35/2012/TT-BLDTBXH dated December 27, 2012, of the Minister of Labor, Invalids, and Social Affairs)

 

 

REPORT

STATUS OF CERTIFICATION ACTIVITY

(From …/…/20... to …/…/20…)

Respectfully submitted to: Occupational Safety and Health Inspection Bureau, Ministry of Labor, Invalids, and Social Affairs

1. Name of designated certification organization:…

2. Address:…

3.Telephone: …Fax:…Email:…

4. Status of activities

………..(name of designated certification organization) reports the status of conformity certification activity from …/…/20... to …/…/20... as follows:

a) Certified entities during the reporting period

b) Entities whose certificates have been revoked or expired (if any) during the reporting period

5. Recommendations and proposals (if any)

……………………………………………………………………………...

…………..(name of designated certification organization) report to the Directorate of Occupational Safety and Health./.